Merck Serono Announces Exclusive License Agreement with Auxogyn for Eeva® Test

• Merck Serono will receive commercialization rights from Auxogyn for the Eeva Test, which is designed to provide objective embryo viability data to IVF clinicians
• Agreement reflects Merck Serono’s and Auxogyn’s commitment to bringing innovative technologies to the IVF community designed to help improve patient outcomes

Darmstadt, Germany, April 3, 2014
Merck Serono, the biopharmaceutical division of Merck, today announced an exclusive license agreement with Auxogyn, Inc., Menlo Park, California, USA, a company dedicated to advancing women’s reproductive health, for Auxogyn’s proprietary Early Embryo Viability Assessment (Eeva®) Test.

Early Embryo Viability Assessment (Eeva®) Test

The Eeva Test is a non-invasive diagnostic test used adjunctively to traditional morphology. It utilizes time-lapse imaging and computer software to analyze embryo development, creating lab-based measurements that provide reproductive endocrinologists and embryologists with objective information which can help to assess embryo development and viability. The Eeva Test results deliver objective information that may assist clinicians in improving IVF (in vitro fertilization) patient outcomes.

“This new agreement further underscores our commitment as a leader in fertility treatment to develop innovative science, medicines and technologies that have the power to improve outcomes for patients throughout the in vitro fertilization process. The Eeva Test can make the difference for the patient, as it can help to objectively identify the embryos with the highest implantation potential,” said Dorothea Wenzel, Head of the Global Business Franchise Fertility at Merck Serono.

“We are excited to further expand our relationship with Merck Serono,” said Lissa Goldenstein, President and Chief Executive Officer of Auxogyn.“With this licensing agreement, Merck’s established commercial expertise will accelerate the availability of the Eeva Test in key international markets and Auxogyn’s innovative test will continue to provide in vitro fertilization clinicians with valuable information that may improve patient outcomes. Most importantly, working together increases our collective ability to enhance outcomes and the chances of having a baby.”

This agreement is a strong reflection of both companies’ commitment to providing clinicians with innovative new technologies that have the potential to benefit patients dealing with fertility issues. Financial details of the agreement are not being disclosed. Under the terms of the agreement, Merck Serono will obtain exclusive rights to commercialize the Eeva Test in Europe and Canada, with the option to extend to selected countries and regions.

The license agreement builds on a successful relationship between the companies that was started in 2010 when Merck Serono initially invested in Auxogyn through a Series A Preferred Stock financing made by Merck Serono’s corporate venture capital fund, MS Ventures. In 2012, Merck Serono and Auxogyn announced a strategic partnership on the Eeva Test.

Dr. Susan Herbert, Executive Vice President, Global Business Development and Strategy for Merck Serono commented: “This agreement is strong validation for our strategy with MS Ventures to invest at an early stage in companies that develop next generation technologies and products that may improve patient outcomes in therapeutic fields that are relevant to Merck Serono.“

Auxogyn received the CE mark for the Eeva System in 2012, and it is currently available for use in certain countries in the European Union and Canada. In the United States, where Auxogyn retains commercialization rights, Auxogyn has filed a submission with the U.S. Food and Drug Administration (FDA) for the clearance of the Eeva System, and this application is currently under review by the FDA.

According to the European Society of Human Reproduction and Embryology (ESHRE), approximately five million additional babies have been born worldwide as a result of assisted reproduction technologies (ART) like IVF since 1978.1 This trend is increasing due to advancements in ART and IVF technologies such as the Eeva Test.

References
1. European Society of Human Reproduction and Embryology. (2012). The world’s number of IVF and ICSI babies has now reached a calculated total of 5 million [Press release]. Retrieved from http://www.eshre.eu/Press-Room/Press-releases/Press-releases-ESHRE-2012/5-million-babies.aspx

About Auxogyn
Auxogyn is revolutionizing the field of reproductive medicine by translating scientific discoveries in early embryo development into clinical tools. The company’s flagship product, the Eeva Test, delivers consistent, objective and quantitative information regarding embryo viability that IVF clinicians and infertility patients can use to make important treatment decisions. Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, MS Ventures, SR One and TPG Biotech.
For more information regarding Auxogyn, please visit http://www.auxogyn.com

About Eeva
Auxogyn’s non-invasive early embryo viability assessment (Eeva) Test when used adjunctively to traditional morphology may improve IVF outcomes by providing IVF clinicians and patients with objective information on embryo viability. The Eeva System utilizes proprietary software that automatically analyzes embryo development against scientifically and clinically validated cell-division timing parameters. With Eeva’s quantitative data on each embryo’s potential development, IVF clinicians can optimize the treatment path for their patients undergoing IVF procedures.
Auxogyn received CE mark for Eeva in July 2012, and it is currently available for use in the select countries in the EU. In the United States, a 510(k) application for the Eeva System is currently under review by the FDA.
For more information regarding Eeva, please visit http://www.eevaivf.com

About MS Ventures
MS Ventures is the strategic corporate venture capital fund of Merck Serono, the biopharmaceutical division of Merck. The fund was established in March 2009 and focuses primarily on early stage investments. MS Ventures has a strategic mandate and invests in companies that develop products and/ or technologies that could benefit patients in therapeutic areas relevant to Merck Serono. MS Ventures has a total of € 140 million under management for strategic investments, investments through its Israel BioIncubator and for spin-offs from the Merck Serono organization.
For more information, please visit http://www.ms-ventures.com

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com

 

46% couples in the age group of 31 – 40 are found to be infertile

– Reveals the first ever fertility survey in India ‘Helping Families’ –
– Endorsed by ASPIRE and ISAR; supported by Merck Serono –

Mumbai, September 19, 2013: ‘Helping Families’, is India’s first ever fertility survey endorsed by the Indian Society for Assisted Reproduction (ISAR), the Asia Pacific Initiative on Reproduction (ASPIRE), supported by Merck Serono. The survey conducted among 2,562 participants and 100 infertility experts from nine Indian cities revealed startling figures. As much as 46% of young couples in the 31 – 40 year age group surveyed were found to be infertile. Out of this group, 49% has already undergone IVF (In vitro fertilization) treatment and the rest of them were considering opting for infertility treatment. 75% of the population studied accepted the benefits of Assisted Reproductive treatment and were of the opinion that procedures like IVF are safe and help in conceiving healthy babies.

When infertility experts were consulted, they shared that 63% of couples seeking infertility treatment are in the age group of 31 – 40. “In male factor infertility, 41% is due to problems concerning sperm (oligospermia or poor sperm count). In female factor infertility, 40% is attributed to poly cystic ovarian disorder (PCOD), followed by tubal factors (35%)”, said noted IVF expert Dr. Hrishikesh Pai, President elect, ISAR 2014 & Scientific Director – Advanced Infertility centre, Lilavati Hospital and Babies & Us, IVF, ICSI clinic.

Left to right – Dr. Hrishikesh Pai, Dr. Jaideep Malhotra and Mr. Lawrence Ganti, Merck Serono India

“India is a vast and, diverse nation. With changing lifestyle, stress and delayed marriages – the incidence of infertility is also on the rise with many other health disorders. 1 out of 10 couples are infertile – hope is on hand – if they reach the right doctors in time. Being the world leaders in fertility treatment, with an estimated 1.8 million babies born thanks to our innovative products, we have helped thousands of couples to realize their dream of having a child. Merck Serono continues to pursue focused research and development in order to offer patients the infertility treatments of tomorrow,” said Mr. Lawrence Ganti, General Manager & Country Head, Merck Serono India.

‘Helping Families’ survey found that couples nowadays expressed great faith in assisted reproductive technological advancements like IVF. Respondents expressed tremendous stress and highlighted the need for immediate positive results.

Dr. Jaideep Malhotra, President elect ASPIRE 2014 & Director, Malhotra Nursing & Maternity Home, stated, “There is a general lack of awareness among the public regarding infertility as it is a taboo subject. In the quest for conception, many couples opt for alternative therapies and religious rituals thus frittering away crucial age and time. Not just that, even today, women are pressurized in all aspects concerning fertility. The stigma and trauma associated with this condition is extreme.”

The decline in fertility started a decade back, with a troubling 17% decrease observed since the year 2000. Compounded by lack of acceptance and doctor checkups, the problem of infertility has raised multi-fold. Nearly 61% of the couples were shown to derive information from sources like the internet and friends. Even in the 21st century, 64% of the couples studied believed in God’s will and delayed treatment, the survey observed.

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About ISAR
With their pan-India presence of 12 chapters, the aim of ISAR is “Better Care of the Concerned Couple, knowledge about their investigations and further education of those who serve them”. For more information, please visit http://www.isarindia.net/

About ASPIRE
ASPIRE, the Asia Pacific Initiative on Reproduction, is a unique task force of clinicians and scientists involved in the management of fertility and Assisted Reproductive Technology (ART). ASPIRE aims to promote awareness of infertility and ART, and to improve infertility-related services in the Asia-Pacific region. For more information, please visit http://www.aspire-reproduction.org

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. We have also been a trusted name and market leader in prescription multi-vitamins for several generations now. Through our areas of expertise and a strong team of more than 1,300 employees in India, we focus on sustainable medical breakthroughs to improve existing treatments and efforts. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono. For more information, please visit www.merckserono.in